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The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumatic leg compression | Experimental | PLC group (i.e., intervention group): Patients assigned to the PLC group will receive a pneumatic lower limb compression sleeve during surgery. |
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| Routine care | No Intervention | Routine care group (i.e., control group): Patients assigned to the Routine care group will not receive a pneumatic lower limb compression sleeve. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic leg compression | Device | Patients assigned to the PLC group will receive a pneumatic leg compression sleeve encompassing the calf and thigh, with sleeve size adjusted according to thigh circumference and manufacturer recommendations. The compression pump will be activated before the start of surgery. After surgery, the responsible trial personnel will deactivate the pump and remove the compression sleeves in the PLC group. There will be no standardized anesthesia management protocol; all decisions regarding hemodynamic management will be made at the discretion of the treating anesthesiologist |
| Measure | Description | Time Frame |
|---|---|---|
| Average norepinephrine infusion rate | Average intraoperative norepinephrine infusion rate [μg kg-1 min-1] needed to keep MAP above 65mmHg. The average intraoperative norepinephrine infusion rate will be calculated using the absolute amount of norepinephrine administered per kg bodyweight [μg kg-1] divided by the duration of surgery (between surgical incision and suture) [min] (continuous outcome) | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Average norepinephrine infusion rate | Average norepinephrine infusion rate [μg kg-1 min-1] needed to keep MAP above 65mmHg. (continuous outcome) | Perioperative |
| Amount of hypotensive events | Amount of hypotensive events with a MAP <65 [mmHg] |
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Inclusion Criteria:
Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes
Exclusion Criteria:
Patients with the following exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| Intraoperative |
| Lowest MAP | Lowest MAP [mmHg] | Intraoperative |
| Cumulative amount of hypotensive time | Cumulative amount of hypotensive time with a MAP <65 mmHg [min] | Intraoperative |
| Time-weighted average MAP <65 mmHg | Time-weighted average MAP <65 mmHg (area under a MAP of 65 mmHg divided by the time from the beginning of induction of general anesthesia until the end) [mmHg] | Perioperative |
| Crystalloid fluid application | Amount of crystalloid fluid application [ml] | Intraoperative |